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510(k) K945876

WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT by Wells Johnson Co. — Product Code EQH

K945876 is an FDA 510(k) premarket notification submitted by Wells Johnson Co. for the device "WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT". The FDA issued a decision of Substantially Equivalent on December 4, 1995. The device falls under product code EQH (Source, Carrier, Fiberoptic Light), a Class I device regulated under 21 CFR 874.4350. Wells Johnson Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1995
Date Received
December 1, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Carrier, Fiberoptic Light
Device Class
Class I
Regulation Number
874.4350
Review Panel
EN
Submission Type

Other clearances by Wells Johnson Co.

  • K991437 — WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00 (August 30, 1999)
  • K984448 — BIRCOLL BALLOON DISSECTOR (January 28, 1999)
  • K971580 — UAS ULTRASONIC ASPIRATOR SYSTEM (December 9, 1997)
  • K945500 — WELLS JOHNSON FIXATION SYSTEM (September 21, 1995)
  • K951519 — WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT (June 14, 1995)
  • K945877 — WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT (March 2, 1995)
  • K945805 — WELLS JOHNSON WECO MONOPOLAR/FRAZIER SUCTION PROBE (December 13, 1994)
  • K854068 — EXTERNAL MECHANICAL FASTENER (November 22, 1985)
  • K843188 — WELLS JOHNSON CO. CHAJ-CHIR-SUCTION TIP (September 20, 1984)
  • K832519 — ASPIRATING TUBING (October 20, 1983)

Other clearances for product code EQH

  • K954184 — JED-LIGHT FIBEROPTIC LIGHT SOURCE (November 13, 1995)
  • K951829 — COLD LIGHT SOURCE LOS 150 (July 10, 1995)
  • K932771 — BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE (August 24, 1994)
  • K941661 — GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT (August 23, 1994)
  • K941662 — GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT (July 20, 1994)
  • K934911 — SAPHIRE PLUS SURGICAL MIRROR (June 21, 1994)
  • K932131 — MID LABS TWIN ILLUMINATOR (April 1, 1994)
  • K930123 — ASPIRATING ENDO OCULAR PROBE (February 16, 1994)
  • K933145 — FIBEROPTIC LIGHTSOURCES AND CARRIERS (September 7, 1993)
  • K923227 — THROAT-A-SCOPE (December 4, 1992)

FDA data resources